BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTREPID AUTOSERT IOL HANDPIECE

    MDR report key: 12576063 · Received October 5, 2021

    Report

    Report Number
    2028159-2021-01148
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    September 1, 2021
    Report Date
    December 27, 2021
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQR
    UDI-DI
    00380657517558
    PMA / PMN Number
    K112425
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN SECTIONS D.10, H.6 AND H.10. THE INJECTOR WAS NOT RETURNED FOR EVALUATION. THE SERIAL NUMBER (S/N) WAS NOT PROVIDED AND COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THEREFORE, MANUFACTURING INFORMATION COULD NOT BE OBTAINED. WITH NO SAMPLE OR ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMER REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT DURING A CATARACT WITH INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IOL HIT TO POSTERIOR CAPSULE CAUSING RUPTURE. THE INITIAL SURGERY WAS COMPLETED WITHOUT IOL REPLACEMENT AND ANY OTHER TREATMENT. THE PATIENT WAS TREATED WITH MOXIFLOXACIN, FLUOROMETHOLONE, BROMFENAC, CEFDINIR, MARSLEN S, ACETAZOLAMIDE, POTASSIUM L-ASPARTATE EYE DROPS. DUE TO POSTERIOR CAPSULE RUPTURE, CONSIDERING THE NECESSITY OF VITREOUS SURGERY, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. IT WAS UNKNOWN IF ADDITIONAL SURGERY WAS PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477444 INTREPID AUTOSERT IOL HANDPIECE APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED HQR ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU 00380657517558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other ACRYSOF IQ IOL.